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Home Whitepaper Periodic Safety Update Report (PSUR) Guidance EU MDR


WHITEPAPER


PERIODIC SAFETY UPDATE REPORT (PSUR) GUIDANCE EU MDR

As per Article 86 and Annex III of the (EU) 2017/745 Medical Device Regulation
(MDR), Periodic Safety Update Report (PSUR) is part of the technical
documentation on post-market surveillance to be drawn up by the manufacturer in
accordance with Articles 83 to 86 throughout the lifetime of the device.

Topics covered in this Whitepaper include:



 * The volume of sales of the device and an estimate evaluation of the size and
   other characteristics of the population using the device
 * Records referring to non-serious incidents and data on any undesirable
   side-effects
 * Information from trend reporting
 * Relevant specialist or technical literature, databases and/or registers
 * Information, including feedbacks and complaints, provided by users,
   distributors and importers
 * Publicly available information about similar medical devices





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